Z-2548-2025 Class II Ongoing
FDA device recall Z-2548-2025 was initiated by Encore Medical, LP on Jul 18, 2025 and is designated Class II. Reason for recall: The reamer may kick or bind up during or immediately prior to use. The recall status is ongoing. Affected quantity: 447 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 17, 2025
- Initiation Date
- Jul 18, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 447 units
Product description
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile Orthopedic instrument for shoulder prosthesis
Reason for recall
The reamer may kick or bind up during or immediately prior to use.
Distribution pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, RI, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico.
Code information
Lot Code: All Lots GTIN: 00190446843818
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2548-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026